Martin Ryner: Automation of the control and analysis to reduce risk of errors in electron microscopy.

The pharmaceutical industry is going through a major transition from small molecule therapies to biologic therapies, with treatments targetting for example hemophilia and genetic blindness. However, biologics such as DNA or RNA based gene therapies, monoclonal antibodies and vaccines need extensive safety controls in order to be released to the public. Many safety and performance releated issues are due to morphological variations in the products. Electron microscopy is used to measure the variations of the biologic structures, but also to detect debris and unwanted aggregation. To use electron microscopy as an analytical tool in quality controlled environments such as pharmaceutical production, automation of the control and analysis is needed to reduce risk of errors. In the seminar we will show a few examples of such analytics, problem areas for control and optimization, machine learning and statistics of the extracted data that is used at Vironova on a daily basis.